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FIBROVEIN 1% SOLUTION FOR INJECTION

Active substance(s): SODIUM TETRADECYL SULPHATE

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Package leaflet: Information for the user
Fibrovein 0.2 %, 0.5 %, 1 % & 3 %
Solution for Injection
sodium tetradecyl sulfate

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your
doctor or nurse.
- If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Fibrovein is and what it is used for
2. What you need to know before you use Fibrovein
3. How to use Fibrovein
4.Possible side effects
5. How to store Fibrovein
6. Contents of the pack and other information
1. What Fibrovein is and what it is used for
The name of your medicine is Fibrovein, which contains
the active ingredient sodium tetradecyl sulfate.
Different strengths of Fibrovein are used in the treatment
of varicose veins, large, medium or minor venules and
spider veins.
This injection belongs to a group of medicines called
sclerosants. Sclerosants are chemical agents, when injected
into the affected vein they cause the lining of the vein walls
to swell and the walls stick together. This stops the flow of
blood and the vein turns into scar tissue. In a few weeks,
the vein should fade.
Fibrovein is only for use in adults (including the elderly).
2. What you need to know before you use Fibrovein
Do not use Fibrovein if you:
• are allergic to sodium tetradecyl sulfate or to any of the
other ingredients of this medicine (listed in section 6) or
have an allergic condition
• cannot walk due to any reason or bedridden
• have risk of developing blood clots in your veins due
to:
• inherited blood disorders such as thrombophilia
• having hormonal contraception or hormone
replacement therapy.
• being significantly overweight
• smoking
• immobility for long duration
• have had recent blood clots in superficial or deep veins
or in the lungs
• have had recent surgery
• have twisted veins (varicose veins) caused by pelvic or
abdominal tumours, unless the tumour has been
removed
• have an uncontrolled ailment such as diabetes,
excessive thyroid activity, asthma, blood abnormality,
blood poisoning, or recent skin or breathing problems
• have swollen or a red area of the skin that feels hot or
tender (cellulitis)
• have any kind of infection
• have evolving cancer
• have been told that you have problems with closing of
valves in deep veins (valvular incompetence)
• have blockage in an artery
• have severe inflammation of veins in the legs (acute
phlebitis)
• have a symptomatic hole in the heart (only if the
sclerosant is used as a foam).

Warnings and precautions
Talk to your doctor before using Fibrovein if you:
• are allergic to any food or medicine or have any other
allergies, you should speak to the doctor before being
given this injection, so that a test dose can be given 24
hours before any further therapy
• have a history of blood clots in superficial or deep veins
or in the lungs
• have an asymptomatic hole in the heart (if the
sclerosant is used as a foam)
• have symptomatic or asymptomatic hole in the heart (if
the sclerosant is used as a liquid)
• suffer from migraines
• have problems with the veins in your legs which is
associated with long-term condition that causes
The following information is intended for healthcare
professionals only:
Fibrovein 0.2 % Solution for Injection
Fibrovein 0.5 % Solution for Injection
Fibrovein 1 % Solution for Injection
Fibrovein 3 % Solution for Injection
Please refer to the Summary of Product Characteristics
(SmPC) for further details of this product.

Posology and method of administration
Posology
Fibrovein is for intravenous use only. The strength of
solution required depends on the size and degree of
varicosity. Spider veins should only be treated with the
0.2%, reticular veins with 0.5%, the 1% solution will be
found most useful for small to medium varicosities and the
3% solution for larger varicosities. The size of non-visible
varicose veins should be measured under ultrasound.
The sclerosant should be administered intravenously in
small aliquots at multiple sites along the vein to be treated
either as a liquid or as a sclerosant/air mixture (foam) as
detailed in the table below. The objective is to achieve
optimal destruction of the vessel wall with the minimum
concentration of sclerosant necessary for a clinical result. If
the concentration is too high necrosis or other adverse
sequelae may occur.
Adults
Concentration
Fibrovein 0.2 %
& 0.5 %
Fibrovein 1%
Fibrovein 3 %

Normal volume injected
Maximum total volume
intravenously at suitable
to be injected per session
sites per session
Liquid
Foam*
Liquid
Foam*
0.1 to 1.0 ml

N/A

0.1 to 1.0 ml 0.5 to 2.0 ml
0.5 to 2.0 ml 0.5 to 2.0 ml

10 ml

N/A

10 ml
4 ml

16 ml
16 ml

* volume is the sum of the liquid and air components
Where special caution is indicated it is recommended that a
test dose of 0.25 to 0.5 ml Fibrovein should be given
followed by observation of the patient for several hours
before administration of a second or larger dose.
As the volume to be injected is limited per session,
repeated sessions are usually needed (2 to 4 on average).
To prevent a possible allergic reaction, it is recommended
that a small test dose of Fibrovein should be given at the
beginning of each session.

swelling in the body’s tissues (Lymphoedema).
Fibrovein may worsen local pain and inflammation for
days or several weeks.
• have a history of pulmonary hypertension
• have a history of stroke or serious cerebral event
• have been told that you have any disease of your
arteries or veins (atherosclerosis)
• have severe inflammation and clotting of arteries and
veins affecting the hands and feet (Buerger’s disease)
• have any breathing difficulties that are controlled
(asthma).
Fibrovein should be administered only by experienced
healthcare professionals experienced in venous anatomy
and familiar with proper injection technique. Before using
this injection you may be tested to see if you have any
problems with the closing of the valves in your veins.
Your doctor will ask you questions about your health and
will inform you about the potential side effects of this
procedure.

injections may be used, however no more than 4 ml is
used when the strongest injection is used.
Due to the limited volume of sclerosant authorised,
repeated sessions of sclerotherapy may be necessary.
After you have been treated with Fibrovein, you should
follow your doctor’s advice. You may be told to wear a
bandage and or/compression stockings to help reduce
inflammation and pigmentation of the skin.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
You may experience some serious side effects. Stop
treatment with Fibrovein and immediately contact your
doctor or go to the nearest hospital emergency
department if you have any of the following:

During treatment
Your doctor will monitor you during and after the
sclerotherapy for signs of hypersensitivity (redness,
itching, cough) or neurological symptoms (visual disorders,
migraine, tingling or numbness).
He will ask you to come back for a follow up visit.

Uncommon (may affect up to 1 in 100 people):
• Blood clots in deep veins (Deep vein thrombosis
possibly due to underlying disease). Symptoms may
include pain, swelling and tenderness in one of your
legs (usually your calf), a heavy ache in the affected
area, warm skin in the area of the clot or red skin
particularly at the back of your leg below the knee.

Children and adolescents
The safety and effectiveness of Fibrovein in children and
adolescents have not been established.

Rare (may affect up to 1 in 1,000 people):
• Local tissue death of skin and more rarely of nerves.
Symptoms include pain, skin discolouration (redness),
swelling or fluid accumulation, blisters (may be filled
with clear fluid or blood), skin turns dark red, purple, or
black, abnormal sensation (tingling, prickling, burning),
numbness or loss of sensation.

Other medicines and Fibrovein
If you are taking hormonal contraception (e.g. ‘the pill’) or
hormone replacement therapy (HRT) you may have a risk
of developing blood clots in your veins (see ‘Do not use
Fibrovein if you’). You must tell you doctor or nurse.
Tell your doctor or nurse if you are taking, have recently
taken or might take any other medicines, including
medicines obtained without a prescription.

Very rare (may affect up to 1 in 10,000 people):
• A very severe form of allergic reaction (anaphylactic
shock), which may cause breathing problems or a
sudden drop in blood pressure making you feel faint or
become unconscious. It is very rare but should be
treated immediately, otherwise it may be fatal.
• Blockage of artery due to a clot which may cause:
• a stroke or an interruption in the blood supply to the
brain or the eye (transient ischaemic attack).
Symptoms may include weakness, numbness or
paralysis in your face, arm or leg, typically on one
side of your body, slurred or garbled speech or
difficulty understanding others, blindness in one or
both eyes or double vision.
• a blood clot in the lungs. Symptoms may include
shortness of breath that may occur suddenly, a
sudden, sharp chest pain that may become worse
with deep breathing or coughing, rapid heart rate or
rapid breathing.
To avoid this very rare serious event, this medicine must
not be given to in patients who have a risk of clots in veins
and arteries (risk of thrombosis).
• Failure of blood circulation. Symptoms may include
fatigue, blackouts, fainting, chest pain, shortness of
breath, weakness, dizziness, vomiting and palpitations.
• Death of tissue following intra-arterial injection.
Symptoms can vary depending on how much medicine
was injected, where it was injected and how quickly
medical attention was received. These can range from
pain but no long-term damage, to loss of large areas of
tissue including the foot, resulting in amputation.

Pregnancy and breast-feeding
You must tell the doctor if:
• you are pregnant or think you may be pregnant
• you are planning on becoming pregnant
• you are breast-feeding
There is no adequate information on the use of Fibrovein in
pregnant women. Fibrovein should not be used during
pregnancy unless clearly necessary. Your doctor will decide
whether or not this treatment is appropriate for you.
It is not known whether Fibrovein is excreted in breastmilk. If you are breast-feeding, the doctor will decide
whether Fibrovein should be used.
Driving and using machinery
After the treatment with this injection, you may be told to
wear a bandage and/or compression stockings to help
reduce inflammation and pigmentation of the skin which
could affect your ability to drive.

Fibrovein contains sodium and potassium
This medicine contains:
• less than 1 mmol sodium (23 mg) per vial/ampoule, i.e.
essentially ‘sodium-free’.
• less than 1 mmol potassium (39 mg) per vial/ampoule,
i.e. essentially ‘potassium-free’.
3. How to use Fibrovein

Other side effects that may be experienced are:

You must not try to inject Fibrovein yourself. You should
always be treated by an experienced doctor who is familiar
with the injection technique.
The therapy involves injecting the medicine into the
affected vein using the smallest of the needles and it is to
be injected slowly and with extreme care so that the blood
content of these veins is expelled. The medicine may be
manually mixed with air using two syringes and a
connector to create a foam to help expel the blood in larger
veins. In this case, it must be administered by a physician
appropriately trained in the correct generation and
administration of foam.
Your doctor should use ultrasound guidance in the
treatment of non-visible varicose veins and for the
administration of foam sclerosant.
Your doctor will decide on the areas to treat and the right
dose for you. The recommended doses are as follows:

Very common (may affect more than 1 in 10 people):
• Superficial inflammation of the vein
Common (may affect up to 1 in 10 people):
• Pain or burning (short term at the injection site)
• Skin discolouration
• Growth of very fine spider veins in the treated area
(matting).

Uncommon (may affect up to 1 in 100 people):
• Local allergic and non-allergic skin reactions e.g.
redness of skin, itchy skin, rash or swelling of the skin
• Visual disturbances.
Rare (may affect up to 1 in 1,000 people):
• Coughing, shortness of breath, sensation of pressure/
tightness in the chest
• Burning, tingling, prickling or itching of the skin
• Headache, migraine, feeling faint
• Confusion, dizziness, loss of consciousness.

Adults and the elderly
• varies between 0.1 and 2 ml for each injection. A
maximum of 10 ml of the three lower strength

Fibrovein 1 % & 3 % Solution for Injection
When the sclerosant is administered as a foam
Fibrovein 1 % and 3 %, may be converted to a foam to be
used for the treatment of larger veins. The foam must be
prepared just before use and administered by a physician
appropriately trained in the correct generation and
administration of foam. It should ideally be administered
under ultra sound guidance.
Fibrovein 0.2 % Solution for Injection
For spider veins the smallest of needles (30 gauge) should
be used to perform the injection which should be made
slowly so that the blood content of these veins is expelled.
In the treatment of spider veins an air block technique may
be used.
Elderly population
No specific dose recommendations apply.
Paediatric population
The safety and efficacy of Fibrovein in children have not
been established. No data are available.
Method of administration
Refer below for instructions for foam preparation. The
Tessari method of preparation of the foam is described.
Other techniques may be used (e.g. DSS, Easyfoam,
Sterivein).
Strict aseptic technique must be maintained while handling
Fibrovein. Fibrovein is a single-use parenteral product.
Once the container is opened, use immediately and discard
any unused portion.
Visually inspect for particulate matter before use. Solutions
that contain particulate matter should not be used.
When the sclerosant is administered as a foam it should
ideally be administered under ultrasound guidance. It must
be administered by a physician appropriately trained in the
correct generation and administration of the foam.

system and familiar with proper injection technique.
Allergic reactions including anaphylaxis have been
reported and the physician should be prepared to treat it
appropriately. Emergency resuscitation equipment should
be immediately available. The patient should be treated in
hospital as a precaution.
Severe adverse local effects, including tissue necrosis, may
occur following extravasation; therefore, extreme care in
intravenous needle placement and using the minimal
effective volume at each injection site are important. The
solution should be injected slowly.
Care should be taken not to inject the solution into an
artery as this may lead to death of the tissue (tissue
necrosis) and may result in loss of the limb.
Special care must be taken when injecting the foot and
above and below the ankle (malleolar area) due to risk to
one of the arteries. Compression must be applied when
treating smaller veins as pigmentation may occur if blood
is expelled at the injection site.

Preparation and handling
General guidelines:
The quality of foam depends on specific criteria:
1. The product concentration: Foam can only be prepared
with concentrations of 1 to 3 % sodium tetradecyl
sulfate.
2. The proportion of liquid to air: Usually, this ratio is 1
volume of liquid for 3 to 4 volumes of air.
3. Number of backwards and forwards passes: The
physician should follow precisely the number of
movements defined for each technique.
4. Macroscopic consistency of the foam: The quality of
the foam should be checked outside of the syringe
before administration. The foam should be
homogeneous, soft and cohesive with no visible large
bubbles. If large bubbles are visible, the foam should be
thrown away and new foam prepared.
5. The total time of preparation of the foam: The
preparation should take around 10 seconds from the
first to the last backwards and forwards movement.
6. The maximum time between preparation and injection:
The sclerosant foam must be used within sixty seconds
of production. After sixty seconds, any remaining foam
should be discarded. More foam should be prepared if
required.

Incompatibilities
This medicinal product is not compatible with heparin.
In the absence of compatibility studies, this medicinal
product should not be mixed with other medicinal
products.

Special warnings and precautions
Fibrovein should only be administered by a healthcare
professional experienced in venous anatomy and the
diagnosis and treatment of conditions affecting the venous

Version No.

12

28/08/12
19-01-17

Kingsway

Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Fibrovein
• Keep this medicine out the sight and reach of children.
• This medicine does not require any special temperature
storage conditions (Temperature Zone 1)
• Do not store above 25°C (For all other Temperature
zones)
• Do not freeze.
• The injection should be stored in the outer carton to
protect it from light.
• Do not use this medicine after the expiry date which is
stated on the label or carton after EXP. The expiry date
refers to the last day of the month.
For single use only. Once the container is opened, the
contents should be used immediately. Any remaining
product should be discarded.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.
6. Contents of the pack and other information
What Fibrovein contains
The active ingredient is sodium tetradecyl sulfate.
For the 0.2 %:
Each ml of solution for injection contains 2 mg sodium
tetradecyl sulfate.
Each 5 ml vial contains 10 mg sodium tetradecyl sulfate.
For the 0.5 %:
Each ml of solution for injection contains 5 mg sodium
tetradecyl sulfate.
Each 2 ml ampoule contains 10 mg sodium tetradecyl
sulfate.
For the 1 %:
Each ml of solution for injection contains 10 mg sodium
tetradecyl sulfate.
Each 2 ml ampoule contains 20 mg sodium tetradecyl
sulfate.
For the 3 %:
Each ml of solution for injection contains 30 mg sodium
tetradecyl sulfate.
Each 2 ml ampoule contains 60 mg sodium tetradecyl
sulfate.
Each 5 ml vial contains 150 mg sodium tetradecyl sulfate.
The other ingredients are: benzyl alcohol (20 mg/ml),
disodium phosphate dodecahydrate, potassium dihydrogen
phosphate, water for injections, sodium hydroxide (to
adjust the pH). See section 2, ‘Fibrovein contains sodium
and potassium’.
What Fibrovein looks like and the contents of the pack
This medicine is presented as a solution for injection in
clear glass ampoules or vials. The solution is clear,
colourless, sterile and free from visible particles.
For the 0.2 %: Pack size 2, 5 or 10 vials of 5 ml
For the 0.5 %: Pack size of 5 ampoules of 2 ml
For the 1 %: Pack size of 5 ampoules of 2 ml
For the 3 %: Pack size of 5 ampoules of 2 ml or 2, 5 or 10
vials of 5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
STD Pharmaceutical Products Ltd.
Plough Lane, Hereford, HR4 0EL, United Kingdom
This leaflet was last revised in: 01/2018

LXXXX

To Prepare the Foam (Tessari technique)
Strict aseptic technique must be maintained while
manufacturing the foam.
To create the foam 1 ml of liquid sclerosant is drawn into a
sterile syringe and 3 ml or 4 ml of sterile air is drawn into
another sterile syringe. The air is drawn through a 0.2 μm
filter to ensure it is sterile. The syringes are then connected
using a sterile three way tap/valve (Fig. 1). The use of Luer
lock syringes and eye protection are recommended when
making the foam. The connection with the 3-way tap can
fail under pressure with Luer slip syringes resulting in
product being squirted out uncontrollably.
The sclerosant/air mixture is then forced back and forth from
one syringe to the other through the 3-way valve at least 20
times to produce a smooth, consistent foam (Fig. 2&3).
The syringe containing the foam, is then removed and the
vein is injected immediately (Fig. 4).
The sclerosant foam should be used within sixty seconds of
production. After sixty seconds any remaining foam should
be discarded. More foam should be prepared if required.
The quality of the foam should be checked before its
administration. It should appear homogenous with no large
bubbles visible to the naked eye.
Figure 1

Figure 2

Figure 3

Figure 4

Excipients
This medicinal product contains:
• less than 1 mmol sodium (23 mg) per vial/am0poule,
i.e. essentially ‘sodium-free’.
• less than 1 mmol potassium (39 mg) per vial/ampoule,
i.e. essentially ‘potassium-free’.

LXXXX

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Very rare (may affect up to 1 in 10,000 people):
• Fever, hot flushes, red itchy skin (hives)
• Nausea, vomiting, diarrhoea, feeling of swollen/thick
tongue, dry mouth
• Inflammation of blood vessels.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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